Citicoline designated novel food ingredient in Europe

Kyowa Hakko's Citicoline’s history of safe use helps to expand market reach.

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) delivered a scientific opinion on Citicoline as a novel food ingredient (NFI), concluding on October 2013 that Citicoline is safe under the proposed uses and use levels.

Commission Implementing Decision 2014/423/EU of 1 July 2014 authorizing Kyowa Hakko the placing on the market of Citicoline as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council.

Citicoline is intended to be used in food supplements in Europe aimed at adult population at a maximum level of 500 mg/day, and in foods for particular nutritional uses, specifically foods for special medical purposes, at a maximum level of 250 mg/serving, and with a maximum daily intake from these types of foods of 1,000 mg/day.

Citicoline is the generic name for CDP-choline (choline cytidine 5’-pyrophosphate), organic molecule produced endogenously and found in all living cells. Is a source of choline and precursor for the synthesis of phospholipids that are essential constituents of cell membranes, including phosphatidylcholine, phosphatidylserine and phosphatidyl-ethanolamine.

In United States, under Cognizin® brand name, Kyowa Hakko USA Inc. has been marketing Citicoline since the early 1980s as dietary supplement and created the trademark name in 2004, received self-affirmed Generally Recognized As Safe (GRAS) status in 2009, as food ingredient for use at levels of 250 mg per serving in such products as dietary supplements, beverages, breakfast cereals, chewing gum, pastas, hard candies, milk products, fruit juices and soft candy.

Cognizin Citicoline is often called a “brain nutrient” because it increases levels of several important neurotransmitters including acetylcholine, dopamine and noradrenaline; helps maintain the integrity of neuronal cell membranes and increases energy production in the frontal cortex.


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